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Landos Biopharma Announces Human Translational Results for Mechanisms of BT-11 in IBD at Digestive Disease Week 2018

June 5, 2018

BLACKSBURG, Va. & WASHINGTON--(BUSINESS WIRE)--Jun 5, 2018--Landos Biopharma, Inc., an emerging biopharmaceutical company focused on developing improved treatments for autoimmune diseases presented findings from mechanisms of action studies for its lead candidate, BT-11 in models of Crohn’s disease (CD) and Ulcerative Colitis (UC) at Digestive Disease Week 2018. The studies demonstrate that through the activation of the Lanthionine Synthetase C-Like 2 (LANCL2) pathway, BT-11 induced changes in the interface of inflammation and metabolism within immune cells in the gut that are critical to provide lasting therapeutic efficacy against inflammatory bowel disease (IBD).

“These mechanistic findings illustrate that BT-11 shows potential to be a powerful oral IBD therapeutic that modulates the interactions between immunological and metabolic signals,” said Andrew Leber, PhD, Scientific Director at Landos. “Importantly, the new data demonstrate the translatability of the therapeutic efficacy of BT-11 to the clinic showing enhanced regulatory CD4+ T helper cell responses and promoting lasting therapeutic actions locally within the gut that may offer a unique opportunity to completely disrupt the IBD treatment paradigm.”

The two primary clinical manifestations of IBD - Crohn’s disease and ulcerative colitis - afflict 2 million North Americans and 5 million people worldwide, with nearly 15% growth over the last five years. There is an unmet clinical need for safer, more effective medications for these diseases as currently marketed therapeutics have a number of drawbacks: they only benefit a small number of the overall population, lose response effectiveness, or cause high rates of side effects, including cancer, infection and death.

The poster (Abstract: Tu1739) titled showed evidence that in human primary cells from the gastrointestinal tract, BT-11 demonstrated therapeutic activity across multiple levels of disease severity and that BT-11 is highly localized to the gastrointestinal tract when dosed orally in four animal species, including pigs. Importantly, the translation of the immunometabolic mechanism to human cells obtained from CD and UC patients is demonstrated in terms of LANCL2 specificity, regulation of critical cytokines involved in IBD, modulation of effector CD4+ T helper cell responses, enhancement of regulatory T cells (Tregs), and activation of immunometabolic pathways. Finally, with a benign safety and toxicology profile at doses up to 1,000 mg/kg, BT-11 may provide a novel approach without dose-limiting safety issues of current or investigational drugs. This data is supportive of recently published findings in Inflammatory Bowel Diseases, the Official Journal of the Crohn’s & Colitis Foundation.

Details from this presentation:

BT-11 decreases inflammatory markers and increases regulatory phenotypes in cells isolated directly from the site of inflammation in CD and UC patients BT-11 reduces production of three prominent inflammatory cytokines, TNFα, IFNγ and IL-4 BT-11 is highly localized to the gastrointestinal tract when dosed orally in four animal species, including pigs with colonic concentrations >10,000 times greater that plasma concentrations BT-11 has a benign safety profile with no dose limiting safety issues identified in doses 100 times higher than the efficacious dose in pre-clinical pharmacology Therapeutic efficacy of BT-11 validated using five well-established models of IBD resulting in 90% reduction in inflammation dependent on immunometabolic mechanisms in regulatory CD4+ T cells.

About BT-11 Landos’ lead product candidate BT-11 is a first-in-class, orally active therapeutic that acts locally in the gastrointestinal tract for treatment of Crohn’s disease and ulcerative colitis. BT-11 has shown outstanding therapeutic efficacy in preclinical models, a benign safety profile without the concerns of systemic exposure and is advancing toward initiation of Phase 1 human trials in Q2 2018. BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract.

About Landos Biopharma, Inc. Landos Biopharma, Inc. is an emerging biopharmaceutical company focused on the discovery and development of first-in-class oral therapeutics for patients with autoimmune diseases. Landos’ lead clinical asset, BT-11, is a novel, oral, locally-acting small molecule targeting the Lanthionine Synthetase C-Like 2 (LANCL2) pathway in the gastrointestinal tract for treatment of inflammatory bowel disease (IBD) and is expected to enter clinical testing for Crohn’s disease and ulcerative colitis in 2018. Landos also has a robust pipeline of compounds for other autoimmune diseases. Landos is headquartered in Blacksburg, VA. For more information, please visit www.landosbiopharma.com or contact info@landosbiopharma.com or follow us @Landosbio.

About Digestive Disease Week Digestive Disease Week ® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place June 2-5, 2018, at Walter E. Washington Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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CONTACT: Company Contacts:

Landos Biopharma:

Josep Bassaganya-Riera, 540-218-1767

jbr@landosbiopharma.com

or

For Media Requests:

LaVoieHealth Science

Sharon Correia, 617-412-8779

scorreia@lavoiehealthscience.com

KEYWORD: UNITED STATES NORTH AMERICA DISTRICT OF COLUMBIA VIRGINIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL

SOURCE: Landos Biopharma, Inc.

Copyright Business Wire 2018.

PUB: 06/05/2018 09:30 AM/DISC: 06/05/2018 09:30 AM

http://www.businesswire.com/news/home/20180605005113/en

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